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Long QT SyndromeRYTHMO'FITNCT05964322

Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

An observational study of Long QT Syndrome and Congenital Long Qt Syndrome, run by University Hospital, Montpellier at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have lower physical and quality of life than their healthy peers. A multi-component cardiac rehabilitation, including an exercise training program and education program, might counteract those effects. Read more about this study

Who is it for?
Ages 6 to 18 years
How many people
8 participants
Where
2 sitesFrance
Study dates
2 Feb 2022to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children aged 8 to 18 years with an LQTS.

  • Children and adolescents, aged 6 to 18 years old, diagnosed with congenital LQTS and had been recently under medical check-up in our last study QUALIMYORYTHM
  • With impaired cardiorespiratory fitness (VO2 peak <80% of predicted values or VAT <55% of predicted values) or with normal cardiorespiratory fitness but requiring patient education and information on limits/security in taking part in sports participation.
  • Willingness and ability for parents and children to take part in a 12-week center-based program (e.g., availability during the school period, transportation options)
  • Informed consent of parents or legal guardians, and oral assent of children.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • University Hospital of Montpellier - Arnaud de Villeneuve Hospita

    Montpellier, 34295

  • Saint-Pierre Institute

    Palavas-les-Flots, 34250

Other trials in France

About this study

Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have lower physical and quality of life than their healthy peers. A multi-component cardiac rehabilitation, including an exercise training program and education program, might counteract those effects.

The goal of this pilot study is to evaluate the security, feasibility, and benefits of a cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old.

The main question[s] it aims to answer are:

  • Is center-based cardiac rehabilitation safe and feasible for children with LQTS?
  • Does a 12-week cardiac rehabilitation program improve physical fitness and quality of life?
Read the detailed description

Physical fitness is an independent predictor of all-cause mortality and global health in the general population. Assessments of cardiorespiratory and muscle fitness in children with chronic illness are growing in interest, even in less prevalent chronic diseases. For instance, children and adolescents with Long QT Syndrome (LQTS) have lower cardiorespiratory fitness, muscle strength, and quality of life than their healthy peers.

A multi-component cardiac rehabilitation including an exercise training program and education program might counteract this lowered physical fitness.

The RYTHMO'FIT pilot study seeks to test the security, and feasibility, and to evaluate the benefits of an innovative center-based program to improve physical and mental health in children and adolescents with LQTS.

In this retrospective study, eight children had undergone a 12-week program, within each session composed by:

  • A 1-hour exercise training session with a trained exercise physiologist: resistance training, aerobic training, stretching, and different activity (e.g., basketball, handball, football, hockey)
  • A 30-min educational workshop with a specialist nurse (e.g., beta-blockade, sports participation, healthy behaviors).
  • A 10-min medical interview with a cardiologist to have feedback from parents and patients on each session and the past 7 seven days.

We hypothesized the RYTHMO'FIT study is safe, feasible, and provides benefits for mental and physical health in children and adolescents with LQTS. If the results of this pilot study are positive, they will lead to a larger randomized multicentric controlled trial to evaluate the effectiveness of a hybrid cardiac rehabilitation program in children, adolescents, and young adults with LQTS.

Keywords
Cardiac Rehabilitation, Long QT syndrome, Pediatric, Exercise training, Educational program
Medical subject headings
Long QT Syndrome, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Security

    Count and specify any cardiac events on the ECG scope during each session. Reporting of related and non-related event during the past 7 days through short questionnaire each week.

    Measured: At week 12

  2. Recruitment rates

    Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).

    Measured: At week 12

  3. Retention rates

    Participants who participated in the 12-week intervention and completed the follow-up assessments at the end of the program (expressed in %).

    Measured: At week 12

  4. Adherence

    Percentage exercise sessions attained by participants compared to number of sessions proposed.

    Measured: At week 12

Secondary outcomes (8)

  1. Change on cardiorespiratory fitness

    Assessing the following variables by cardiopulmonary exercise testing: peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT), ventilatory efficiency (VE/VCO2 slope), maximum heart rate (HR), oxygen pulse (VO2/HR), maximal power, respiratory exchange ratio.

    Measured: between week 0 and week 12

  2. Change on muscle architecture

    Assessing the following variables by ultrasounding: Anatomical cross sectional area, pennation angle, fascicle length and muscle thickness

    Measured: between week 0 and week 12

  3. Change on muscle strength

    Lower and upper limb maximal isometric strength by knee extension and handgrip test, respectively. Lower body explosive muscular strength was assessed by standing long broad jump.

    Measured: between week 0 and week 12

  4. Change on physical activity level

    Time spent in vigorous, moderate-to-vigorous, light physical activity assessed by waist-worn tri axial accelerometer during 7 days.

    Measured: between week 0 and week 12

  5. Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire

    Measured: between week 0 and week 12

  6. Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)

    Measured: between week 0 and week 12

  7. Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)

    Measured: between week 0 and week 12

  8. Change on cardiological outcomes

    Electrocardiographic at rest (QTc, heart rate, PR, QRS interval time) and echocardiography (LVEF, IVSd, IVSs, LVEDV, E/A ratio)

    Measured: between week 0 and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start2 Feb 2022
  3. Primary completion7 Mar 2023
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964322
Sponsor's protocol ID
RECHMPL23_0225
Acronym
RYTHMO'FIT
Status last verified
Jul 2025
First submitted
4 Jul 2023
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022.

    PubMed 36712265

  • Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.

    PubMed 34321045

  • Souilla L, Guillaumont S, Auer A, Metzler G, Requirand A, Vincenti M, De La Villeon G, Pasquie JL, Mottet D, Amedro P. Cardiac rehabilitation in children and adolescents with long QT syndrome: the RYTHMO'FIT pilot study. BMC Sports Sci Med Rehabil. 2024 Jul 12;16(1):152. doi: 10.1186/s13102-024-00941-2.

    PubMed 38997778

Questions about this trial

What is this clinical trial studying?

An observational study of Long QT Syndrome and Congenital Long Qt Syndrome, run by University Hospital, Montpellier at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Security (time frame: At week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05964322, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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